Ultrasonographic Assessment of Carpal Tunnel Syndrome

NCT02196220 | Completed

• 1 other identifier: 59910
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo syndromes. These patients have a genetic enzyme deficiency that results in the inability to degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell enlargement and subsequent dysfunction. The accumulation occurs in all tissues including cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits, and various other orthopaedic manifestations \[Van Heest, White\]. These children often suffer from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal tunnel syndrome is almost always present, but may not become apparent until symptoms are severe and loss of function has occurred. The current gold standard for diagnosis consists of electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general anesthetic \[Khanna\]. Primary Objective: The investigators plan to correlate EMG findings and median nerve cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the need for EMG studies and anesthesia. Secondary Objective: The investigators want to determine the cross-sectional area of the median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The investigators plan to evaluate a cohort of healthy children to determine a normal cross-sectional area of the median nerve.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Median nerve cross-sectional area in children with mucopolysaccharidosis and a cohort of healthy children, ages 3-12.

  6-weeks after open carpal tunnel release

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study Size: \*150 total which includes the following: Arm 1: 25 Children with mucopolysaccharidosis Arm 2: 100 Control Group - Healthy children ages 3-12 with no previous history of upper extremity trauma or history of mucopolysaccharidosis.

You may qualify if:

• For the first arm of the study (25 participants):
• Children with mucopolysaccharidosis presenting to the senior author's clinic with signs or symptoms of carpal tunnel syndrome will be enrolled to receive both an EMG and carpal tunnel ultrasound of the upper extremities.
• For the second arm of the study (100 participants):
• Healthy children ages 3-12 with no acute upper extremity trauma or history of mucopolysaccharidosis.
• additional participants requested in case of inconclusive ultrasound results, patient removal, or other unusable results.

You may not qualify if:

• First arm:
• Children with mucopolysaccharidosis who have undergone previous treatment for carpal tunnel syndrome.
• Second arm:
• Acute (\<3month) wrist or hand surgery/injuries.
• Unable to obtain parental consent or patient assent.
• History of mucopolysaccharidosis.
• Non-english speaking.
• Cognitive impairment.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah/Primary Children's Medical Center

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Douglas T Hutchinson, M.D.

  University of Utah Orthopedic Center

  PRINCIPAL INVESTIGATOR

• Amy Moeller, M.D.

  University of Utah Orthopedic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)